Tranexamic Acid 1 g/10mL
Tranexamic Acid · INJECTION, SOLUTION · Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
Tranexamic Acid is a injection, solution containing tranexamic acid at 1 g/10mL, taken intravenous. Manufactured by Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc..
Key Facts
- Brand Name
- Tranexamic Acid
- Generic Name
- Tranexamic Acid
- NDC Code (Product)
23155-166- Manufacturer
- Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
- Strength
- 1 g/10mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203521
- Drug Class
- Antifibrinolytic Agent [EPC]
- Marketing Start
- 08/13/2014
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
AuroMedics Pharma LLC
Presence of Particulate Matter: Piece of metal found in a vial
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Amring Pharmaceuticals Inc
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Mylan Institutional LLC
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
AVKARE LLC
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Fresenius Kabi USA, LLC
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy. ( 2.1 ) After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 1 mL/minute to avoid hypotension. ( 2.1 ) Reduce the dosage for patients with renal impairment. ( 2.2 , 8.6 ) 2.1 Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight intravenously administered as a single-dose, immediately before tooth extractions. Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions ( 5.1 )]. Following tooth extraction, tranexamic acid injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. Heparin ma…
Contraindications
4 CONTRAINDICATIONS Tranexamic acid injection, USP is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. In patients with active intravascular clotting [see Warnings and Precautions ( 5.1 )] . In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions ( 5.4 )] . In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction. ( 4 ) In patients with active intravascular clotting. ( 4 ) In patients with severe hypersensitivity reactions to tranexamic acid or any of the ingredients. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. ( 5.1 , 7.1 , 8.3 ) 7.1 Prothrombotic Medical Products Avoid concomitant use of tranexamic acid injection with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.3 )] .
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions ( 5.1 )] Seizures [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Visual Disturbances [see Warnings and Precautions ( 5.5 )] Dizziness [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy Inc. at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tranexamic acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction. Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous…
Frequently Asked Questions
What is Tranexamic Acid used for?
Tranexamic Acid contains Tranexamic Acid. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Tranexamic Acid a controlled substance?
Tranexamic Acid is not classified as a controlled substance by the DEA.
What is the generic name for Tranexamic Acid?
The generic name for Tranexamic Acid is Tranexamic Acid. There are 5 other brand versions of Tranexamic Acid.
What is the NDC code for Tranexamic Acid 1 g/10mL?
The NDC (National Drug Code) for Tranexamic Acid 1 g/10mL is 23155-166, listed by Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc..